Truffle Report has compiled a roundup of major psychedelic business news stories from the week of January 10-14, making it easier for you to access these insights in one place.
atai Life Sciences
Psychedelics sector leader atai Life Sciences announced on Wednesday that it had received Investigational New Drug clearance from the U.S. Food and Drug Administration for PCN-101. This R-ketamine compound will be the subject of a clinical drug-drug interaction trial by atai platform company Perception Neuroscience, conducted in the hope of offering a rapid effect and decreased risk of suicidality to a patient population currently dependent on SSRI antidepressants.
“We see great promise in PCN-101 as a potentially rapid-acting antidepressant with a more favorable safety and tolerability profile than S-ketamine, which could enable at-home use,” said Florian Brand, CEO and Co-Founder of atai Life Sciences. “With today’s IND clearance, we are excited to continue assessing the therapeutic potential of PCN-101 in the U.S., where, like elsewhere in the world, many patients struggle with treatment-resistant depression and desperately need innovative therapeutic options.”
Psychedelic Business News: Field Trip Health
The United States Patent and Trademark Office has issued Field Trip Health a notice of allowance for it’s claims concerning its patent on FT-104, Field Trip’s novel psychedelic compound currently in development.
Notices of allowance are an important step in the granting of patents, and occur after the USPTO has reviewed the application for compliance.
Dr. Nathan Bryson, Field Trip’s Chief Science Officer, commented: “Since inception, the strategy at Field Trip for our first development project was to create a novel drug substance that could produce a consistent trip time, in the range of three hours. We achieved this by combining a novel prodrug strategy to make demonstrable improvements on a known class of psychedelic substances. To further derisk the project, we filed a Track One U.S. patent application on June 30, 2021 in order to accelerate the decision by examiners and achieve allowance, and granting, as early as possible in the development process. We are elated that the USPTO has formally allowed our patent application within seven months of filing and are now poised to continue development of FT-104 knowing that we have a robust intellectual property position to build on.”
Mydecine announced on Thursday that it would be launching a Special Access Support and Supply Program, in line with Health Canada’s recent amendments to the Special Access Program. These recent changes to federal regulations will allow doctors to request psychedelic medicines for patients with serious or life-threatening conditions, to be approved on a case-by-case basis by the ministry. Mydecine is a manufacturer of pharmaceutical grade psilocybin and MDMA.
CEO Josh Bartch commented that, “The goal of our Special Access Support and Supply Program, is to help physicians who want to prescribe these treatments to their patients but might not have access to the drug product in Canada or experience implementing psychedelic-assisted psychotherapy. It’s extremely encouraging to see these much-needed treatments gaining government acceptance, and now we need to enable successful therapy outcomes. Outside of safe drug products, practitioners need access to the resources and the proper training to provide these treatments to their patients. By launching this program, we are providing the resources the thousands of non-psychedelic clinics and hospitals will need in order to safely and effectively integrate these therapies into existing medical practices.”
The release included a form for interested parties to request more information on Mydecine’s program.
Psychedelic Business News: Wesana Health Holdings Inc.
Wesana Inc announced on Tuesday that it’s request for a pre-IND meeting with the United States Food and Drug Administration has been granted. Wesana will meet with the FDA to discuss the Investigational New Drug application of SANA 0-13, it’s combination CBD/psilocybin protocol for the treatment of Traumatic Brain Injury, or TBI.
“This is a thrilling milestone in my nearly-decade long effort to find and advocate for treatments that provide hope to brain injury survivors,” said Daniel Carcillo, Wesana founder and CEO. “People who are suffering with severe TBI-related depression have a fivefold increase in suicide attempts and are 3 to 4 times more likely to die by suicide12. They deserve to have the best diagnostics and treatment options available to them, including a pharmaceutical option that doesn’t exasperate symptomology. We look forward to being able to move SANA-013 to a Phase I clinical trial as soon as possible.”